There has long been rapid hype in the biotechnology sector. The same owing to various legal and scientific advancements. However, it is very difficult to receive patents in this sector and involves many complex issues. This article let us understand why this is and look at perspectives of Indian and US laws in view of the same.
What is a microorganism?
- “Any living thing that is invisible to the naked eye and can be seen only under a microscope is called a microorganism. They include BACTERIA, protists, and some fungi, such as yeasts. VIRUSES are usually included, but they are not really living organisms.”[1]
Why is it difficult to patent microorganisms?
- Now, the logic behind the fact is this: since microorganisms are considered living things, you cannot patent it. As that would suggest you own a living thing. And what happens when you own a living thing? It amounts to slavery.
So, in short, there are ethical and moral factors to consider when patenting a microorganism. Majorly, on these grounds’ patents are usually rejected. However, the laws have evolved since then and allow patenting if certain criteria are met.
Let us take the example of the case Diamond vs Chakraborty. In this case, Mr. Dr. Anand Chakraborty developed or invented a micro-organism that solves the issues of oil spills. Now, usually in cases of oil spill, which is spilt in the larger ocean or otherwise, there are no way to clean it up. The same ends up damaging the entire environment and aquatic animals. Naturally, he wanted to get the same patented and approached the US Patent Office, which later rejected the patent on the grounds that, “Living things cannot be patented” under 35 U.S.C. § 101. This case was appealed till Supreme Court. The Court rejected the US Patent Officer’s decision and held that there are certain factors that need to be considered when granting patents to microorganism:
- It has to be an invention and not just a mere discovery,
- Such invention has to be novel,
- It needs to serve for a larger commercial purpose.
In the present case, Dr. Chakraborty fulfills all the above criteria. Hence, patent was granted.
Points of Significance held in this case
- “Whether a thing is alive or not is irrelevant to patent law. Significant is alone whether it is a product of nature or of human invention.
- The Court in subsequent case law confirmed the non-patentability of natural substances such as isolated DNA (Myriad case) and natural phenomena (Mayo case).
- The criteria of “manufacture” and “composition of matter” in the US provision on patentable subject matter are interpreted to have a very large scope.”[2]
Before the US Supreme Court’s decision in the case of Diamond v. Chakrabarty, Patent protection was not granted to microorganisms as product claims, but only to the process claims in which microorganisms was used as a medium in inventions.[3]
The Indian Patents Act, 1970 included patenting microorganisms under the Patents (Amendment) Act, 2002, in accordance with the TRIPS Agreement 1994. In accordance with Section 3(j) of the Patents Act, 1970, a plant, animal, seeds and biological processes, apart from microorganisms are not patentable.[4] Thus, this Section under the Act, allows patentability of microorganisms.
The landmark judgment of the Calcutta High court in the case of “Dimminaco A.G. v. Controller of Patents & Designs on 15th January 2001, prior to the 2002 amendment in the patents act, 1970 established a benchmark in the field of micro-biological research. In this case, an appeal was filed against the Assistant Controller of Patents & Designs, wherein, the process for preparation of infectious Bursitis Vaccine was refused on the grounds that the process of preparation of vaccine that contained a living virus cannot be considered manufacture and that a vaccine comprising of a living virus cannot be considered a substance or inanimate object. The court in this case reversed the decision of the Assistant controller and held that, the process of preparing a vendible commodity containing a living substance is not excluded from the purview of the word, ‘manufacture’ and that the controller erred in denying patent protection to the vaccine just because it contained a live virus. Furthermore, the end product was novel, capable of industrial application and was useful for protecting poultry against contagious Bursitis infection, thus making the process an invention. The court further allowed the appeal and directed the petitioner’s patent application to be reconsidered within two months of the publication/delivery of the judgement.”[5]
Conclusion: There is broad scope under Patents law, the same is however not unlimited. It is important to note that in the case of Dr. Chakraborty, where the Court’s main notion was that he was trying to patent something, he himself developed. micro-organisms with human interventions, accompanied by novelty, utility and industrial applicability are patentable. However abstract ideas, or creation of something out of already existing organism do not constitute invention. Therefore, one should do their due diligence and take full responsibility and precaution.
[1] DK Nature: Microorganisms (factmonster.com) [2] Case name (unctad.org) [3] Patenting of microorganisms: Systems and concerns, Ramkumar Balachandra Nair & Pratap Chandran Ramachandranna .Journal of Commercial Biotechnology volume 16, pages 337–347(2010) access from: https://link.springer.com/article/10.1057/jcb.2010.20. [4] Article | Asia IP - Intellectual Property News and Analysis (asiaiplaw.com) [5] Microorganisms And The Indian Patents Scenario - Intellectual Property - India (mondaq.com)
